{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Indianola",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "75387",
      "recalling_firm": "Bayer Healthcare",
      "address_1": "1 Bayer Dr",
      "address_2": "N/A",
      "postal_code": "15051-9702",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide and internationally to : Taiwan, Ukraine, Turkey, Thailand, Slovania, Singapore, Sweden, Saudi Arabia, Serbia, Romania, Qatar, Portugal, Poland, Panama, Oman, Norway, The Netherlands, Mexico, Malta, Morraco, Libyan, Lithuania, Lebanon, Kuwait, Italy, Israel, Hungray, United Kingdom, France, Finland, Spain, Denmark, Germany, Czech Republic, Chile, Switzerland, Belguim, Bosnia, Austria, Australia,",
      "recall_number": "Z-0400-2017",
      "product_description": "PET Infusion Pump",
      "product_quantity": "165,127 (79,714 units in U.S.)",
      "reason_for_recall": "The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date.",
      "recall_initiation_date": "20160930",
      "center_classification_date": "20161111",
      "termination_date": "20170324",
      "report_date": "20161123",
      "code_info": "Impacted Batch Numbers: 20044  8401230  20110777  20110778  20129053  20130260  20143029  20168043  20168044  20218499  20223554  20226461  20229069  50378230  50508655  50514420  50515055  50515057  50562833  50562834  50562835  50562836  50572481  50574207  50574208  50574209  50585611  50586105  50596605  50597703  50597850  50600435  50601580  50602572  50604785  50606331  50620077  50629437  50632873  50634213  50657181  50663447  50665086  50669881  50677540  50686154  50688724  50693453  50695189  50696540  50696563  50698651  50699741  50699882  50699883  50705397  50705398  50718205  50718756  50720431  50721421  50725617  50725618  50731457  50735273  50738861  50740290  50743615  50747279  50748947  50750243  50752501  50755005  50781643  50782219  50783201  50784811  50786091  50786092  50786096  50789117  50789131  50789132  50792077  50793811  50795111  50798463  50801293  50801294  50804590  50804591  50808994  50812469  50826288  50826491  50826492  50827614  50827615  50828779  50831229  50831230  50833827  50834754  50836287  50837233  50838024  50840343  50840344  50841688  50843787  50845969  50847291  50848267  50848268  50848269  50853167  50855436  50856405  50857510  50860994  50866789  50867921  50869464  50869465  50871131  50872965  50878229  50878230  50878231  50878232  50881328  50881393  50881394  50881395  50881506  50881511  50881512  50882753  50886316  50886467  50886468  50886469  50888285  50888286  50888287  50888373  50890483  50890484  50890485  50892357  50892358  50892359  50892360  60000321  60000790  60000833  60000835  60000914  60000973  60001065  60001078  60001558  60001766  60001767  60001864  60002113  60002164  60002324  60002467  60002845  60002846  60003127  60003128  60003256  60003265  60003368  60003703  60004022  60004099  60004159  60004454  60004625  60004711  60005487  60006206  60006545  60006624  60007219  60007220  60007221  60007925  60008270  60008271  60008539  60008540  60008541"
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